Cardiovascular disease (“CVD”), which includes heart disease, is a class of diseases that involve the heart, the blood vessels (arteries, capillaries, and veins) or both. Cardiovascular disease refers to any disease that affects the cardiovascular system, principally cardiac disease, vascular diseases of the brain and kidney, and peripheral arterial disease. The causes of cardiovascular disease are diverse but atherosclerosis and/or hypertension are the most common.
Cardiovascular disease is the number one cause of death worldwide. Accordingly to WHO March 2013 Fact Sheet N 317, an estimated 17.3 million people died from CVDs in 2008, representing 30% of all global deaths. Of these deaths, an estimated 7.3 million were due to coronary heart disease and 6.2 million were due to stroke. The number of people who die from CVDs, mainly from heart disease and stroke, will increase to reach 23.3. million by 2030. CVDs are projected to remain the single leading cause of death. Therefore, there exists a need to develop new CVD treatments.
Major Adverse Cardiovascular Events (“MACEs”) include three primary measurements: nonfatal myocardial infarction (“MI”), nonfatal stroke, and cardiovascular death. These major adverse cardiovascular events represent serious ischemic events and are widely used endpoints in cardiovascular outcome trials.
In view of the foregoing, there is a need to develop effective treatments to reduce the risk of MACE in patients at an increased risk of MACE.
Obesity has been defined in terms of body mass index (BMI). BMI is calculated as weight (kg)/[height (m)]2. According to the guidelines of the U.S. Centers for Disease Control and Prevention (CDC) and the World Health Organization (WHO), for adults over 20 years old, BMI is categorized as follows: below 18.5 is considered underweight, 18.5-24.9 is considered normal, 25.0-29.9 is considered overweight, and 30.0 and above is considered obese (World Health Organization. Physical status: The use and interpretation of anthropometry. Geneva, Switzerland: World Health Organization 1995. WHO Technical Report Series).
In most of the anti-obesity drug clinical studies, people with type 1 or 2 diabetes and other serious medical conditions such as increase risk of major adverse cardiovascular events (MACE) are excluded. As such, there is a need to develop effective anti-obesity treatments in these at risk patient populations.